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Completed

NCT Number: NCT03034408

Nalmefene, Baclofen and Impulsivity in Subjects With Alcohol Use Disorder and Healthy Control Subjects

Impulsivity is a central feature of addiction. Nalmefen is an authorized treatment for alcohol addiction. Baclofen has empathically been advocated to have some efficacy in this indication. The aim of the present study is to test the effect of Nalmefene and Baclofen on impulsivity.

Primary study objective: To examine the effect of Nalmefene and Baclofen on impulsivity (as measured by the Stop Signal Task) in subjects with alcohol use disorder and healthy control subjects.

Main secondary study objectives: To examine the effect of Nalmefene and Baclofen on risk taking (as measured by the Balloon Analogue Risk Task) and on the preference for small immediate rewards over large delayed rewards (as measured by the Delay Discounting Task). To compare subjects with alcohol use disorder and healthy control subjects on these tasks.

Primary study outcome: Stop-signal reaction time in the Stop-Signal Task Main secondary study outcomes: Equivalence point in the Delay-Discounting Task and Average number of pumps delivered in the Balloon Analogue Risk Task

Study Design: Randomized, placebo control, cross-over, single-dose

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Key information

Conditions

Alcohol Use Disorder Alcohol-Related Disorders Alcoholism Behavior Chemically-Induced Disorders Impulsive Behavior Mental Disorders Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Service d'Addictologie, Hôpitaux Universitaires de Genève

Geneva, 1202, Switzerland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 30 patients with DSM-5 Diagnosis of Alcohol Use Disorder, at least moderate (303.90/F10.20),
  • 30 sex and age-matched healthy controls,
  • over 18, informed consent.

Exclusion criteria

  • opiate-treatment,
  • contra-indications for Nalmefene and/or Baclofen,
  • unstable psychiatric disorder,
  • pregnancy,
  • acute withdrawal syndrome.

Treatment and study plan

Nalmefene

Drug

Other names: Selincro

Baclofen

Drug

Other names: Lioresal

Placebo oral capsule

Drug

Other names: Mannitol

Primary outcomes

  1. Change in "Stop-signal reaction time" in the Stop-Signal Task

    Time frame: 0 and 2 hours post-dose

    Before-drug/after-drug difference of the stop-signal reaction time in the Stop Signal Task at Visit 2, Visit 3 and Visit 4.

Secondary outcomes

  1. Change in "Equivalence point" in the Delay-Discounting Task

    Time frame: 0 and 2 hours post-dose

    Before-drug/after-drug difference of the Equivalence point" in the Delay-Discounting Task at Visit 2, Visit 3 and Visit 4.

  2. Change in "Average number of pumps" delivered in the Balloon Analogue Risk Task

    Time frame: 0 and 2 hours post-dose

    Before-drug/after-drug difference of the "Average number of pumps" delivered in the Balloon Analogue Risk Task at Visit 2, Visit 3 and Visit 4.

Sponsors and collaborators

Lead sponsor

Prof. Daniele Zullino

Other

Registry information

Official study title

Effects of Nalmefene and Baclofen on Impulsivity in Subjects With Alcohol Use Disorder and Healthy Control Subjects: A Randomized, Placebo-controlled Study

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jan 27, 2017
Registry last updated
Oct 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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